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Phidisa Project: STATUS SINCE 02/08/2003 Col J.J. Msimang Director DMCOC 26/07/2004

Phidisa Project: STATUS SINCE 02/08/2003 Col J.J. Msimang Director DMCOC 26/07/2004. Make better, prolong lives. SCOPE. Accomplishments of the Project since July 2003 Challenges of a Clinical Trial in a Military Setting Objectives of the Upcoming Year Goals to Attain Objectives.

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Phidisa Project: STATUS SINCE 02/08/2003 Col J.J. Msimang Director DMCOC 26/07/2004

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  1. Phidisa Project:STATUS SINCE 02/08/2003 Col J.J. Msimang Director DMCOC 26/07/2004 Make better, prolong lives

  2. SCOPE • Accomplishments of the Project since July 2003 • Challenges of a Clinical Trial in a Military Setting • Objectives of the Upcoming Year • Goals to Attain Objectives Make better, prolong lives

  3. Governance Structure: 2003 Make better, prolong lives

  4. Governance Structure: 2004 EXECUTIVE COMMITTEE Maj Gen M Radebe; Brig Gen N Motumi; Dr C Lane; Dr S Brodine HJF HIGHVELD OFFICE CONSULTANTS DATA MANAGEMENT COORDINATION AND OPERATIONS CENTRE RESEARCH SITES 1 ,2, 3, Mil Hospitals Mtubatuba Sickbay Umtata Sickbay Phalaborwa Sickbay Make better, prolong lives

  5. Accomplishments • November 2003: • Human Resources for HJF, DMCOC and the two Sites • Procurement of Antiretroviral drugs for Phidisa II • December 2003: • Data Management Coordination and Operations Centre • (DMCOC) established • 2 Protocols, CRFs & Manual of Operation Implemented • Project Phidisa Launched Make better, prolong lives

  6. Accomplishments Cont… • December 2003 (Cont…): • Initial training • Web site launched • January 2004: • Planned CRO visits to Monitor Clinical Sites Scheduled • Telecommunication Systems linking DMCOC and Sites • Enrollment at two Phidisa Sites Make better, prolong lives

  7. Accomplishments Cont… • January 2004: • Two Sites Operational and their Pharmacies functional • US Visiting Physicians and Nurses • Data Capturing • Internet System Connectivity between DMCOC and Sites • February 2004: • Randomization of Phidisa Participants Make better, prolong lives

  8. Accomplishments Cont… • April 2004: • Short-Term Budget System • Initial Data Analysis • June 2004 • NIH Training for Phidisa Physicians Make better, prolong lives

  9. CHALLENGES • Assimilation of a unique Research Project within the Military • Seamless Human and Material Resource Support • Integration of Macro Financial Resources • Command and Control • Macro Cross Impact Flux • Defined Target Values • Military Vs Civilian Dynamics (Consistency of Contracts) Make better, prolong lives

  10. OBJECTIVES • Review the Business Plans • Review Policies and Procedures • Launch Outstanding Sites • Ensure Robust Data Management System • Coordinate Communications • Coordinate Information Technology • Provide Capacity Building Make better, prolong lives

  11. OBJECTIVES (Cont…) • Phidisa III Protocol Operational • Provide Biostatistics Services • Provide Laboratory Services • Provide ART and Patients Care • Review New Needs • Regulate Protocol Implementation Make better, prolong lives

  12. GOALS Make better, prolong lives

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